Ubrogepant for Pediatric Migraine

(Ubro Peds Trial)

Recruiting at 128 trial locations

Overseen By ABBVIE CALL CENTER

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Allergan

Must not be taking: Opioids, Barbiturates, Triptans, others

Disqualifiers: Chronic migraine, Psychiatric conditions, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 6 months

1059 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test if ubrogepant is safe and effective for young people with migraines. Ubrogepant is a medication taken by mouth to treat migraine headaches. It works by blocking a protein in the brain that causes migraine pain. The study focuses on children and adolescents who suffer from migraines.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, if you are taking any medication that is on the list of prohibited medications, you may need to discontinue or switch to an alternative medication.

What data supports the effectiveness of the drug Ubrogepant for treating pediatric migraine?

Research shows that Ubrogepant is effective for treating acute migraine in adults, as it helps reduce pain and other bothersome symptoms during a migraine attack. This suggests it might also be effective for pediatric migraine, although specific studies in children are needed. ^{1 2 3 4 5}

Is Ubrogepant safe for treating migraines?

Ubrogepant has been shown to be generally safe for treating migraines in adults, with studies confirming its safety over a 52-week period. However, its long-term safety in a large population and in combination with other treatments still needs more research. ^{2 6 7 8 9}

How is the drug Ubrogepant unique for treating pediatric migraine?

Ubrogepant is unique because it is an oral medication that works by blocking the calcitonin gene-related peptide (CGRP) receptor, which is involved in migraine attacks. This mechanism is different from traditional migraine treatments that often focus on pain relief after the headache starts. ^{1 3 4 9 10}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for children and adolescents aged 6-17 with a history of migraines, experiencing 1-14 attacks per month. They must have tried at least one oral migraine medication and their migraines should last between 3-72 hours if untreated. Exclusions include drug abuse, certain gastrointestinal conditions, specific types of migraines like hemiplegic or retinal, significant neurological disorders other than migraine, frequent hospital treatments for migraines, suicide risk, hypersensitivity to CGRP receptor antagonists or any study components.

Inclusion Criteria

I have tried at least one over-the-counter oral medication for my child's migraines.

My child has had migraines for at least 6 months.

My child experiences 1-14 migraine attacks monthly.

Exclusion Criteria

I can swallow pills or can learn to do so.

I have had 1 to 14 moderate to severe migraines each month for the last 2 months.

You have expressed thoughts of hurting yourself or others in the past 6 months, or have attempted to hurt yourself in the past 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral tablets of ubrogepant or placebo for qualifying migraine attacks, with an option for a second dose or rescue medication

Up to 6 months

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment, including medical assessments, blood tests, and questionnaires

4 weeks

Treatment Details

Interventions

• Placebo-Matching Ubrogepant
• Ubrogepant

Trial Overview The trial tests the safety and effectiveness of Ubrogepant—an approved adult migraine treatment—in young patients during acute migraine episodes. Participants will be split into two age groups (6-11 and 12-17) and randomly assigned to receive either a low or high dose of Ubrogepant or a placebo in a double-blind manner. There's a chance they'll get the placebo instead of the actual drug.

Participant Groups

Group I: PK Cohort: Ubrogepant Dose B Experimental Treatment 1 Intervention

Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.

Group II: PK Cohort: Ubrogepant Dose A Experimental Treatment 1 Intervention

Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.

Group III: Main Study: Children Ubrogepant Low Dose Experimental Treatment 1 Intervention

Participants aged 6 to 11 (after dose selection) will receive oral tablets of low dose ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.

Group IV: Main Study: Children Ubrogepant High Dose Experimental Treatment 1 Intervention

Participants aged 6 to 11 (after dose selection) will receive oral tablets of high dose ubrogepant Dose B for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.

Group V: Main Study: Adolescents Ubrogepant Low Dose Experimental Treatment 1 Intervention

Participants aged 12 to 17 will receive oral tablets of ubrogepant low dose for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.

Group VI: Main Study: Adolescents Ubrogepant High Dose Experimental Treatment 1 Intervention

Participants aged 12 to 17 will receive oral tablets of ubrogepant high dose or qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.

Group VII: Main Study: Children Ubrogepant Placebo Placebo Group 1 Intervention

Participants aged 6 to 11 (after dose selection) will receive oral tablets of placebo-matching ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of placebo-matching ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.

Group VIII: Main Study: Adolescents Ubrogepant Placebo Placebo Group 1 Intervention

Participants aged 12 to 17 will receive oral tablets of placebo-matching ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of placebo-matching ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.

Ubrogepant is already approved in United States for the following indications:

Approved in United States as Ubrogepant for:

• Acute treatment of migraine in adults

Who Is Running the Clinical Trial?

Allergan

Lead Sponsor

Trials

782

Recruited

277,000+

Brent Saunders

Allergan

Chief Executive Officer since 2015

JD and MBA from Temple University

Dr. David Nicholson

Allergan

Chief Medical Officer since 2015

MD from Harvard Medical School

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

In a Phase 3 clinical trial involving 1686 participants, ubrogepant demonstrated significantly greater efficacy than placebo for acute migraine treatment, with 21.8% of patients achieving pain freedom at 2 hours after taking the 50 mg dose.

Ubrogepant 50 mg also resulted in a higher rate of absence of the most bothersome migraine-associated symptom compared to placebo, indicating its potential effectiveness in alleviating multiple aspects of migraine attacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Ubrogepant vs Placebo on Pain and the Most Bothersome Associated Symptom in the Acute Treatment of Migraine: The ACHIEVE II Randomized Clinical Trial. Lipton, RB., Dodick, DW., Ailani, J., et al.[2021]

A comprehensive analysis of 2,067 reports from the FDA Adverse Event Reporting System revealed that Ubrogepant, used for treating acute migraines, is associated with various adverse events, including nausea, dizziness, and new reports of hemiparesis and mental impairment.

The study highlights the importance of monitoring Ubrogepant's long-term safety, as it identified new adverse events not previously documented in clinical trials, enhancing our understanding of its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Ubrogepant-related adverse events using the FDA adverse event reporting system. Cao, B., Gu, S., Shen, Z., et al.[2023]

Ubrogepant significantly improves pain freedom and reduces bothersome migraine symptoms within 2 hours compared to placebo, with 20.8% of patients achieving pain freedom versus 12.6% for placebo in a meta-analysis of three trials involving 3326 patients.

Short-term use of ubrogepant does not increase the risk of treatment-related adverse events compared to placebo, indicating it is a safe option for acute migraine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ubrogepant for the Acute Treatment of Episodic Migraine: A Meta-Analysis of Randomized Clinical Trials. Yang, Y., Chen, M., Sun, Y., et al.[2021]

In a phase 3 trial involving 518 participants, ubrogepant 100 mg significantly reduced the occurrence of moderate or severe headaches when taken during the prodrome phase of a migraine, with 46% of treated events showing improvement compared to 29% with placebo (p<0.0001).

Ubrogepant was found to be well tolerated, with a slightly higher incidence of adverse events (17%) compared to placebo (12%), indicating it is a safe option for acute migraine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA. Dodick, DW., Goadsby, PJ., Schwedt, TJ., et al.[2023]

In a pooled analysis of 2,247 participants from the ACHIEVE I and II trials, ubrogepant demonstrated similar efficacy in treating acute migraine regardless of whether participants were using preventive medications, indicating it is effective for both groups.

The safety profile of ubrogepant was also consistent, with no significant differences in treatment-emergent adverse events between those on preventive treatments and those not, suggesting it is a safe option for acute migraine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant Is Safe and Efficacious in Participants Taking Concomitant Preventive Medication for Migraine: A Pooled Analysis of Phase 3 Trials. Blumenfeld, AM., Knievel, K., Manack Adams, A., et al.[2022]

Ubrogepant, a calcitonin gene-related peptide receptor antagonist, has been shown to be significantly more effective than placebo in providing relief from migraine pain within 2 hours, with odds ratios indicating strong efficacy at both 50 mg and 100 mg doses.

This medication is a safe and effective alternative for patients who cannot tolerate traditional migraine treatments like NSAIDs or triptans, making it an important option for those with limited treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant: An Oral Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist for Abortive Migraine Treatment. Nedd, M., Garland, S., Falk, N., et al.[2022]

In a 52-week trial involving 1230 participants, ubrogepant (50 mg and 100 mg) was found to be safe and well-tolerated for the acute treatment of migraines, with low rates of treatment-related adverse events (10% for 50 mg and 11% for 100 mg).

The most common side effect was upper respiratory tract infection, and there were no serious liver-related issues, indicating that ubrogepant does not significantly impact liver function, which is crucial for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Safety Evaluation of Ubrogepant for the Acute Treatment of Migraine: Phase 3, Randomized, 52-Week Extension Trial. Ailani, J., Lipton, RB., Hutchinson, S., et al.[2021]

Ubrogepant, a CGRP receptor antagonist approved by the FDA, has been shown to be effective in providing pain relief from migraines, outperforming placebo in Phase III trials (ACHIEVE I and II) within 2 hours of administration.

The 52-week open label extension of these trials confirmed the safety of ubrogepant, although a real-world study indicated higher adverse event rates, highlighting the need for further research on its long-term safety and efficacy, especially when used with other CGRP therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant in the Acute Management of Migraine: A Narrative Review. Chiang, CC., VanderPluym, JH.[2021]

In a pooled analysis of 2240 participants from two phase 3 trials, ubrogepant 50 mg demonstrated significant efficacy in achieving pain freedom at 2 hours post-dose, with 20.5% of participants reporting this compared to 13.0% in the placebo group (P < 0.001).

Ubrogepant also showed a favorable safety profile, with similar rates of adverse events (11.5% for placebo vs. 11.2% for ubrogepant), and no serious adverse events related to treatment were reported, indicating it is a well-tolerated option for acute migraine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant for the Acute Treatment of Migraine: Pooled Efficacy, Safety, and Tolerability From the ACHIEVE I and ACHIEVE II Phase 3 Randomized Trials. Hutchinson, S., Dodick, DW., Treppendahl, C., et al.[2023]

Ubrogepant (Ubrelvy™) is a highly-selective CGRP antagonist that was approved in December 2019 for the acute treatment of migraines in adults, marking a significant advancement in migraine therapy.

As an orally administered medication, ubrogepant offers a new option for adults suffering from migraines, providing a targeted mechanism of action that specifically blocks the CGRP pathway involved in migraine attacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant: First Approval. Scott, LJ.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of Ubrogepant vs Placebo on Pain and the Most Bothersome Associated Symptom in the Acute Treatment of Migraine: The ACHIEVE II Randomized Clinical Trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Evaluating Ubrogepant-related adverse events using the FDA adverse event reporting system. [2023]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ubrogepant for the Acute Treatment of Episodic Migraine: A Meta-Analysis of Randomized Clinical Trials. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Ubrogepant Is Safe and Efficacious in Participants Taking Concomitant Preventive Medication for Migraine: A Pooled Analysis of Phase 3 Trials. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Ubrogepant: An Oral Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist for Abortive Migraine Treatment. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Long-Term Safety Evaluation of Ubrogepant for the Acute Treatment of Migraine: Phase 3, Randomized, 52-Week Extension Trial. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Ubrogepant in the Acute Management of Migraine: A Narrative Review. [2021]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Ubrogepant for the Acute Treatment of Migraine: Pooled Efficacy, Safety, and Tolerability From the ACHIEVE I and ACHIEVE II Phase 3 Randomized Trials. [2023]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Ubrogepant: First Approval. [2020]